Replies to post #145305 on Innovation Pharmaceuticals Inc (IPIX)

[TheHound]

FDA Feedback Received for Phase 3 Trial of Brilacidin-ABSSSI

Cellceutix has received a response from the U.S. Food and Drug Administration ("FDA") regarding the Company's Special Protocol Assessment ("SPA") for its Phase 3 Trial of single-dose Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI). The FDA reviewed the Company's SPA submission and has requested certain changes be made to the protocol, as is typical procedure (see 'About SPA Agreements' below). Cellceutix will be scheduling a meeting with the FDA to discuss the proposed protocol changes toward finalizing the agreement. Meanwhile, the Company is moving ahead in matters of clinical supply procurement and study sites selection.

About SPA Agreements

Obtaining Special Protocol Assessment (SPA) designation from the FDA is an important step as it reinforces the potential of a promising drug in clinical development. The SPA agreement delineates key statistical and clinical endpoint requirements, streamlining the process toward a product gaining FDA approval should the agreed upon criteria and outcomes be met. The SPA process itself can be iterative in nature. In fact, according to industry data, 78 percent of SPAs require multiple review cycles and an average of three months to finalize the SPA. For more information about the FDA's SPA program, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.

"We are extremely proud of Brilacidin as it represents the first potential new class of antibiotics to treat serious skin infections in some twenty plus years and very much look forward to the start of the Phase 3 ABSSSI trial as soon as our SPA discussions with the FDA conclude," stated Leo Ehrlich, Chief Executive Officer of Cellceutix. "There is a huge unmet medical need, worldwide, for newer and better antibiotics, with the market likely to gravitate toward single-dose drugs like Brilacidin. Commonly praised by clinicians once introduced to it, Brilacidin is positioned to help fill this void, and in the process, further unlock shareholder value. In addition, we see the ABSSSI clinical trials as a gateway for Brilacidin's use in bacterial biofilm infections and its use in the treatment of diabetic foot infections."